FDA Clarifies Compliance Date and other Aspects Concerning the Final Rules for the Nutrition Facts Label and Serving Size

As we previously reported, FDA issued final rules updating the nutrition labeling regulations, 21 C.F.R. §§ 101.9 and 101.36, and the serving size regulation, 21 C.F.R. § 101.12, on May 27, 2016. Despite the rather extensive preamble, the final rules left many questions unanswered. FDA promised to address a number of issues in guidance. The timing of that guidance is crucial because the compliance date for the final rules is July 26, 2018 (smaller businesses with annual food sales of less than 10 million dollars have until July 26, 2019).

Early in August, 2016, FDA created a webpage with industry resources which provided some answers. Then, on January 4, 2017, FDA announced the availability of two arguably overdue draft guidance documents: a draft guidance clarifying aspects of the final rule regarding nutrition labeling, and a draft guidance providing examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) used to determine serving size.

Compliance date: In August, 2016, FDA interpreted compliance date to mean that food products that are initially introduced into interstate commerce on or after that date would need to include the new version of the Nutrition Facts and Supplement Facts labels. Apparently, this statement resulted in more questions. So, FDA revised its thinking and, according to the draft guidance, will consider the date the food product is labeled for purposes of the compliance date. The location of a food in the distribution chain (e.g., is the product in the warehouse of the manufacturer or in the warehouse of the distributor) is not relevant. In the draft guidance, FDA also clarifies that the 10 million dollar annual sales limit need not be met for all three years prior to the date of the final rule (i.e., 2013, 2014, and 2015), but is met if the smallest sales volume from one of these previous three years is less than 10 million. The sales do, however, concern total food sales, i.e., domestic and international.

Added sugars: Not surprisingly, since the requirement for listing added sugars is a new (and probably the most controversial) requirement, about 50% of the draft guidance covers questions and answers about the calculation and declaration of “added sugars.” Questions include scenarios for when a juice concentrate constitutes an added sugar, how to declare added sugars in fermented foods, how to determine added sugars when Maillard browning occurs, whether fruit powders and pastes are added sugars, and compliance criteria. FDA provides some helpful examples. The Federal Register Notice announcing the availability of the draft guidance also includes a request for comments to three specific questions regarding added sugars and fruit or vegetable juice concentrates.

In the discussion, FDA acknowledges that sugars, whether added or naturally present, are biochemically equivalent. The added sugars, however, provide consumers a measure of “empty calories.”

Rounding of the declaration of quantitative amounts of vitamins and minerals: The new requirement to declare the quantitative amounts (in addition to the percentage Daily Value) of vitamins and minerals (excluding sodium) in the Nutrition Facts box also generated some questions and uncertainties. In response to these questions, FDA prepared a table specifying the recommended rounding of the vitamins and minerals. In addition, the draft guidance discusses the basis for these recommendations.

The draft guidance regarding RACCs provides examples of food products that belong to each product category included in the tables of Reference Amounts Customarily Consumed (RACCs) that may be useful for industry in identifying the correct food category (and therefore the serving size) for a product. Although few may be surprised to see that all watermelon falls in the category of watermelon, the fact that bagel thins are not bagels (with a RACC of 110 g) but are bread (with a RACC of 55 g) may be less obvious. The guidance provides examples, not an all-inclusive list of all products on the market (see here).

The draft guidances are accessible on the industry resources webpage. That page also includes a link to the draft guidance for Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (Comments due February 13, 2017).